FDA Halts Sale of Transvaginal Surgical Mesh in U.S.

The U.S Food and Drug Administration (FDA) ordered manufacturers of transvaginal surgical mesh to stop selling and distributing its products in the United States. Transvaginal mesh is used to repair pelvic organ prolapse and stress urinary incontinence in women.

At issue: the FDA said it “has determined the manufacturers, Boston Scientific and Coloplast have not demonstrated a reasonable assurance of safety and effectiveness for these devices.”

Pelvic Organ Prolapse

Pelvic organ prolapse (POP) is a common condition in women. It happens when the muscles and tissues supporting the pelvic organs – the bladder, uterus and rectum – become loose or weak. When this happens, one or more of the pelvic organs may drop into the vagina or press into it.

Stress Urinary Incontinence

Stress Urinary Incontinence (SUI) is the unintentional loss of urine that happens when physical movement or activity such as coughing, running, sneezing or heavy lifting puts pressure on a woman’s bladder.

Transvaginal Surgical Mesh

In the 1990’s surgeons began implanting surgical mesh for the transvaginal repair of POP. In 2002, the first mesh device for transvaginal repair of POP was cleared for use by the FDA.

The agency concluded Boston Scientific and Coloplast failed to provide an adequate assessment of the long-term safety of the devices compared to using native tissue for the surgical repair of prolapse or incontinence.

What to Do

If you have had transvaginal mesh in a procedure, the FDA recommends continuing with your routine, annual and follow-up check-ups. There is no need to take action unless you are having symptoms, complications or are dissatisfied with your surgery.

FDA Warning: Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse


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About The Author

Christopher Shakib

Christopher Shakib

Chris began his career fighting for victims’ rights as a state prosecutor of violent criminals. From 1992 to 1996, he prosecuted bad guys and witnessed the life-long harm criminals inflicted on their victims, because they made a conscious decision to do wrong, often for financial gain.